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FDA 510(k)

Unity Subcutaneous Delivery System for Remodulin

K-Number: K190182 · 2019-05-06

ApplicantDEKA Research & Development
Decision Date2019-05-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Unity Subcutaneous Delivery System for Remodulin is the device name listed in this FDA 510(k) record. The listed applicant is DEKA Research & Development. It received FDA 510(k) clearance on 2019-05-06 under 510(k) number K190182. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unity Subcutaneous Delivery System for Remodulin?

Unity Subcutaneous Delivery System for Remodulin is a medical device that received FDA 510(k) clearance on 2019-05-06. The listed applicant is DEKA Research & Development. The 510(k) number is K190182.

When did Unity Subcutaneous Delivery System for Remodulin receive FDA 510(k) clearance?

Unity Subcutaneous Delivery System for Remodulin received FDA 510(k) clearance on 2019-05-06, under 510(k) number K190182.

Who is the listed applicant for Unity Subcutaneous Delivery System for Remodulin?

The FDA 510(k) record lists DEKA Research & Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unity Subcutaneous Delivery System for Remodulin?

The FDA product code for Unity Subcutaneous Delivery System for Remodulin is FRN.

Other records listing DEKA Research & Development as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250930twiist systemK250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionK243354Remunity SystemK191313Unity Subcutaneous Infusion System for RemodulinK172601Next Generation iBOTK153760Volumetric Infusion Controller

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Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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